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Pfizer Announces International Approval of tofacitinib

Pfizer Inc (NYSE: PFE) announced that its drug, tofacitinib, has been approved for the treatment of rheumatoid arthritis (RA) in patients who had a disappointing response to existing therapies in countries around the world including Switzerland.

Tofacitinib 5 and 10 mg twice-daily has been approved for the treatment of RA as a monotherapy (a single drug regimen) or in combination with a disease modifying non-biologic antirheumatic agent like methotrexate (MTX) in adults with moderate to severe active RA and were either unable to tolerate MTX or had an inadequate response.

Tofacitinib 5 mg BID has also been approved in Argentina, Kuwait and the United Arab Emirates, and tofacitinib 5 mg and 10 mg BID has been approved in Russia. The brand name for tofacitinib in the approved markets will be XELJANZ, except for Russia, where the brand name will be Jaquinus®.

The 5 mg version of the drug was already approved in the United States and Japan for the treatment of moderate to severe RA. It was launched in the United States last year and became available in Japan this month.

 “More than 23 million people worldwide are living with rheumatoid arthritis and there remains an unmet need for additional treatments, with up to one-third of RA patients not adequately responding and about half who stop responding to any particular DMARD within five years,” said Geno Germano, president and general manager, Specialty Care and Oncology, Pfizer. “XELJANZ has a novel mechanism of action for the treatment of moderate-to-severe RA. With these approvals, we believe XELJANZ has the potential to change the way rheumatologists treat this chronic, and potentially disabling, disease, and we are proud to offer patients and physicians an additional treatment option.”

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Disclosure: At the time of this writing, the author had no position in the company mentioned.

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